All original observations, calculations and derived data, calibration, validation and verification records etc. and final results must be retained on record for an appropriate period of time e.g.

whole length of time the drug is on the market

Records to contain sufficient information to permit repetition of tests and include e.g.

identity of the personnel involved in sampling, preparation and testing of the samples

Instruments, equipment etc.

Part One. 4.1 4.2. 38Quality Control

Records must be

Legible and readily retrievable

Stored and retained in a manner that prevents modification, damage or deterioration and/or loss

Held secure and in confidence

Includes reports from internal audits and management reviews and records from possible corrective and preventive actions

Part One. 4.3. 39Quality Control

Analytical worksheet

An internal document in a printed form for recording information

Complemented by the raw data obtained in the analysis

One used for each numbered sample

A further set of analytical worksheets in duplicate can be used for a collaborating unit (after testing, all results are assembled in one analytical worksheet, using the data from all collaborating units).

Part Three. 15.1. 15.3.2. 40Quality Control

The analytical worksheet must provide or leave space for the following information

registration number of the sample

page numbering including total number of pages (including annexes)

date of the test request

date of analysis performed

name and signature of analyst

description of the sample received

reference to the specifications to which the sample was tested including limits (adding any or special methods employed) - reference number of the specifications, if available (e.g. pharmacopoeia monograph)

Part Three. 15.4.1. 41Quality Control

The analytical worksheet must provide or leave space for the following information (cont)

results obtained of tested sample

the interpretation of the results and the final conclusions, signed by each of the analysts involved and initialled by the supervisor

the identity of the test equipment used

further comments, for example, for internal information

Part Three. 15.4.1. 42Quality Control

The above information may be complemented by

detailed notes on the specifications selected and the methods of assessment used

whether and when portions of the sample were forwarded to other units for special tests (for example, mass spectrometry, x-ray diffraction), and the date when the results were received

identification number of any reference material

if applicable, data to be attached of an instrument verification

if applicable, data to be attached of a reagent verification.

Part Three. 15.4.1. 43Quality Control

The completed analytical worksheet must be signed by the responsible analyst/s and initialled by the supervisor.

Specifications necessary to assess the sample

Particular pharmacopoeia monograph

Manufacturers specifications

National pharmacopoeia to be used

Specifications contained in the product licence, and should be the current version

Reference materials have assigned values of a quantity. Hierarchy for reference materials

Primary chemical substance

has appropriate qualities within a specified context, and whose value is accepted without requiring comparison to another chemical substance

Secondary chemical reference substance

- characteristics are assigned and/or calibrated by comparison with a primary chemical reference substance. The extent of characterization and testing of a secondary chemical reference substance may be less than for a primary chemical reference substance. This definition may apply inter alia to some substances termed working standards.

International Biological Standards

a category of biological reference material having World Health Organisation (WHO) status

Part Two. 13.5.1. 13.5.3. 46Quality Control

Reference materials

Used for testing and/or calibration, validation or verification of a sample or equipment, instruments or other devices

Responsibility must be assigned to a specific person

Registration and labelling with an identification number assigned

A new identification number to each new batch

Number marked on each vial

Quoted on the analytical worksheet at every use

Part Two. 11.1. 11.2.4. 47Quality Control

Central register for reference materials containing information

identification number of the material

precise description of the material

source

date of receipt

batch designation or other identification code

intended use of the material (e.g. as an infrared reference material, as an impurity reference material for thin-layer chromatography, etc.)

location of storage in the laboratory, and any special storage conditions

further indications (e.g. results of inspections).

Part Two. 11.3.1 11.3.2. 48Quality Control

Information file for reference materials containing information

In addition to the central register - a file containing information on the properties of each reference material

Working standards - include the results of all tests and verifications

Inspections must be recorded in the central register and/or the information file

See also "The general guideline on the establishment, maintenance and distribution of reference materials"

Part Two. 11.4.1. 11.6. 49Quality Control

5. Data processing equipment

Includes computers, automated tests or calibration equipment used for collection, processing, recording, reporting, storage or retrieval of test- and/or calibration-data

Where used, requires systematic verifications of calculations and data transfers

For computer software developed by the user

this documented in detail

validated or verified as being adequate for use

Part One. 5.1. 50Quality Control

5. Data processing equipment

Located in suitable environmental supporting operating conditions

Maintenance of computers and automated equipment

Procedures established and implemented for protecting data integrity

Include e.g. integrity and confidentiality of data entry or collection, data storage, transmission and processing

Procedures in place to describe how

Changes are made, documented, and controlled for information maintained

To protect and keep back-up data at all times

To prevent unauthorized access or amendments to the data.

Part One. 5.1. 51Quality Control

Reagents

Reagents, chemicals, including solvents and materials used in tests and assays - of appropriate quality and supplied with COA

List of pre-qualified suppliers

Clear responsibility in job descriptions for the preparation of reagents in the laboratory

SOPs according to pharmacopoeia or other standards

Records for the preparation, and standardization of volumetric solutions

Part Two. 10.1. 10.3. 52Quality Control

Reagent labels must clearly specify

the contents, the manufacturer, the date received, and as appropriate, the concentration, standardization factor, shelf-life and storage conditions (purchased)

date of preparation, name and initials of person (if prepared in the laboratory)

Volumetric solutions

the name of the manufacturer of the original reagent (where diluted), the date of preparation, the date of standardization and factor, and identify the responsible technician

Reagents must not be moved unnecessarily from unit to unit

Whenever possible, transportation in original containers

Subdivided in scrupulously clean, fully labelled containers

Part Two. 10.4-10.5.3. 53Quality Control

Inspect reagent containers when delivered (e.g. seals intact)

Inspection recorded on the label giving the date, name and initials

If tampered with, rejected, unless identity and purity can be confirmed

Distilled water and deionized water

Water should be considered as a reagent.

Precautions to avoid contamination during

supply, storage and distribution.

To comply with pharmacopoeia and other official requirements for quality.

Part Two. 10.6.1. - 10.6.4.3 54Quality Control

Calibration, validation and verification of equipment, instruments and other devices

Regular calibration, validation and verification of all equipment, instruments and other devices used to measure the physical properties of substances must be performed

Specific procedures for each type of equipment, instrument and other devices must be established, having regard to the extent of which they are used, verified and calibrated at regular intervals according to SOP

Part Two. 12 -12.2. 55Quality Control

The records must include at least the following

name of equipment, instrument and other devices

manufacturer's name, type identification, serial number or other unique identification

verification/calibration to comply with the specifications

current location, where appropriate

the manufacturer's instructions, if available, or reference to their location

Part Two. 12.5. 56Quality Control

The records must include at least the following (2)

dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria, and due date of next verification/calibration

maintenance carried out to date and the maintenance plan

history of any damage, malfunction, modification or repair. It is also recommended to keep records and additional observations of the time, the equipment, instruments or devices were used

Defective instruments - taken out of service, and clearly labelled or marked

Status of calibration and the date when recalibration is due, indicated

Instruments to be satisfactory before being returned to service

Part Two. 12.6. 12.10. 58Quality Control

Performing the tests

Official pharmacopoeia requirements - see general notices and the specific monographs of the pharmacopoeia

System suitability done as relevant

All values obtained from each test, including blank results, must immediately be entered on the worksheet, and all graphical data, whether obtained from recording instruments or hand-plotted must be attached to the analytical worksheet

Doubtful results can be rejected only if they are clearly due to error, which has been identified.

All conclusions entered on the analytical worksheet by the analyst and initialled by the supervisor

Part Three. 17.1. 17.2. 60Quality Control

Analytical test report must provide the following information

registration number

name and address of laboratory testing the sample

name and address of originator requesting analysis

name and description and batch number of the sample, where appropriate

reference to the specification(s) used for testing the sample including limits

results of all tests performed, numerical results of all tests performed (if applicable)

conclusion whether or not the sample was found to meet the limits of specifications

Part Three. 17.3.2. 61Quality Control

Analytical test report must provide the following information (cont)

date of test performed

signature of the head of the laboratory or authorized person

name and address of repacker/trader, if applicable

name and address of original manufacturer

compliance to requirements

date received

expiry date.

Part Three. 17.3.2. 62Quality Control

Traceability

Analytical specificities of each measurement procedure and reference material that is used to ascertain traceability, must be known.

Traceability chain, including measurement procedures and reference materials at all levels, must be prepared

Laboratory investigations - applies to measurement procedures as well as to reference materials used

Part Two. 13.1. 13.3. 63Quality Control

Filing

Analytical worksheet filed for safe keeping together with any attachments, including calculations and tracings of instrumental analyses

Analytical test report must be prepared on the basis of the worksheet

Mistakes, amended data or text - old information may be deleted by a single line (not erased nor made illegible) and the new information added alongside, initialled or signed, and an explanation for the change given

adequate insulation and spark-proofing of electrical wiring and equipment, including refrigerators

observation of safety rules in handling cylinders of compressed gases and familiarity with their colour identification codes

awareness of avoiding solitary work in the laboratory

provision of first-aid materials and instruction in first-aid techniques, emergency care, and use of antidotes

Part Four. 19.2. 68Quality Control

Protective clothing must be available, including eye protection, masks and gloves

Water showers should be installed

Rubber suction bulbs used on manual pipettes and siphons

Staff must be instructed in the safe handling of glassware, corrosive reagents, and solvents, and particularly in the use of safety containers or baskets to avoid spillage from containers

Warnings, precautions and instructions must be given

Safe disposal of unwanted corrosive or dangerous products by neutralization or deactivation

Safe and complete disposal of mercury and its salts

Part Four. 19.3. 69Quality Control

Poisonous or hazardous products

Singled out and labelled appropriately

Unnecessary contacts with reagents, especially solvents and their vapours, must be avoided

The use of known carcinogens and mutagens must be limited or totally excluded if required by local regulations

Replacement of toxic solvents and reagents by less toxic materials or reduction of their use

Part Four. 19.4 70Inspecting the QC laboratory

Thank you

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